Sterilization - Integra Padgett B Guía De Usuario

Integra Padgett
®
Electric Dermatome Models B and PI

Sterilization

The Integra Padgett Electric Dermatome Models B and PI are provided NON-STERILE and
must be sterilized prior to use. The sterilization cycle parameters outlined below have been
validated for the Integra Padgett Electric Dermatome Models B and PI.
Steam Sterilization:
Cycle
Conditions
Wrapped Pre-Vacuum
Wrapped Gravity
Wrapped
Pre-Vacuum-UK Cycle
Wrapped Pre-Vacuum
- French Cycle
NOTE: Ensure sufficient cooling time after the sterilization process to allow the dermatome
temperature to equilibrate to ambient room temperature.
Never immerse instrument, even to cool. This will result in the unit being damaged and
needing repair.
Note: It is the sole responsibility of the end user to validate alternate sterilization
methods and cycles that do not comply with the validated sterilization methods
and cycles specified within this manual.
ETO Sterilization:
The Integra Padgett Electric Dermatome Models B and PI have been successfully validated for
ethylene oxide sterilization to the parameters specified below:
For Wrapped Configurations subjected to 100% Ethylene Oxide (EO) Sterilization, the
following parameters apply:
Precondition the chamber to the specified exposure temperature and 55% relative
humidity for a minimum of one (1) hour. The 100% Ethylene oxide concentration is
725 mg/L. Note the specified exposure temperatures and times, as well as Aeration times
as listed in Table 2 below:
21
®
Exposure
Temperature
132°C (270°F)
132°C (270°F)
134°C -0/+3°C
(274°F -0/+5°F)
134°C -0/+3°C
(274° F - 0/+ 5° F)
Exposure Time
4 minutes 40 minutes
15 minutes 50 minutes
3 minutes 50 minutes
18 minutes 50 minutes
Dry Time